Roche submits filing to FDA for companion diagnostic for NSCLC drug therapy Roche announced it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval, or PMA, to the FDA, as a companion diagnostic test for AZD9291, an AstraZeneca (AZN) investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation. Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca's novel therapy.

Analyst says Chinese Internet firms seeing 'healthy' consumer demandChinese Internet stocks are among the many classes of Chinese stocks traded in New York that are weak this morning, though research firm Pacific Crest wrote in a note to investors today that after traveling to China and conducting checks, the firm is more upbeat on e-commerce company 58.com (WUBA), online travel agency Qunar (QUNR) and online video company Youku Tudou (YOKU). WHAT'S NEW: After speaking with Chinese advertising and e-commerce companies, as well as with Chinese companies that are exposed to online services, Pacific Crest analyst Cheng Cheng believes that consumer demand for Internet products and services is "stable and healthy." The decline in the stocks of Chinese Internet companies has created buying opportunities, Cheng believes. He identified 58.com and Qunar as his favorite picks in the sector heading into second quarter results. Both stocks have declined about 20% over the last 1-2 months, but the core businesses of both companies are accelerating, the analyst stated. Specifically, most of 58.com's end markets "are showing strong or at least healthy underlying demand," while Qunar is poised to benefit from an acceleration of demand for its hotel rooms, the analyst believes. Meanwhile, Youku is benefiting from strong demand from advertisers, wrote Cheng, who kept Overweight ratings on 58.com and Qunar and maintained a Sector Weight rating on Youku. WHAT'S NOTABLE: Cheng added that he remains "positively biased" towards Baidu (BIDU) and Alibaba (BABA). Baidu is slated to report its second quarter results tonight. He kept Overweight ratings on both stocks. PRICE ACTION: In late morning trading, 58.com slid 4.6% to $62, Qunar retreated 5.7% to $40.65 and Youku fell 4.7% to $19.20 amid broad weakness in Chinese stocks trading in New York after China's home Shanghai composite index fell 8.5% overnight.

Keryx appoints Scott Holmes as CFOKeryx Biopharmaceuticals announced the appointment of Scott A. Holmes to CFO effective immediately. Holmes will be responsible for Keryx's finance function and will be a member of the company's executive team. He will succeed James Oliviero whose planned departure was announced earlier this year. Oliviero will stay with the company through a transition period. Holmes brings nearly 20 years of life sciences and financial management expertise to Keryx. He joins the company from AMAG Pharmaceuticals where he most recently served as senior vice president, finance and investor relations during a period of high growth driven by acquisitions and public financings. Prior to AMAG, from 2009 to 2011, he was vice president of finance and treasurer of Molecular Biometrics.

Genzyme acquires Caprelsa from AstraZeneca for $300MGenzyme, a Sanofi (SNY) company, announced that it has entered into a definitive agreement with AstraZeneca (AZN) to acquire Caprelsa, a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300M, including an upfront payment of $165M to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135M. The transaction does not include the transfer of any AstraZeneca employees or facilities.

Piper cuts Array target by only 50c after failed trialPiper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.

AstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.